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Device Review Decision Tree Version Date: 3-5-12

Device Review Decision Tree Version Date: 3-5-12. Does this study involve the clinical investigation to determine the safety and effectiveness of a device? ( e.g. – Are you evaluating the device for safety and efficacy? ). Yes: FDA Regs apply. No: FDA Regs DO NOT apply.

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Device Review Decision Tree Version Date: 3-5-12

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  1. Device Review Decision TreeVersion Date: 3-5-12 Does this study involve the clinical investigation to determine the safety and effectiveness of a device? ( e.g. – Are you evaluating the device for safety and efficacy? ) Yes: FDA Regs apply No: FDA Regs DO NOT apply Is study exempt from IDE Regulations ? Answer NO if an In-vitro diagnostic device. Is the device a Research Use Only Device (RUO)? No Yes Is the device an in-vitro diagnostic device? Yes Will results be used to diagnose or treat subjects? NO Yes Yes Do all other procedures fit under an expedited criteria Does the device being used have FDA approval for any indication? No Yes NO Will other procedures require study to be reviewed by full board? (e.g all procedures do not fit under expedited criteria or study is not minimal risk ) YES Is study minimal risk? No NO Do all other procedures fit under an expedited criteria? No Yes To Full Board for Review. As expedited criteria # 4 not applicable. DO NOT use Expedited Criteria # 1 as the device is not being evaluated therefore FDA regulations do not apply. NOTE: FB does NOT determine SR/NSR status but may determine if protocol is minimal risk, therefore allowing future continuations to be expedited via category # 9. Category # 9: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories (2) through (8) do not apply but the IRB has determined and documented at a convened full IRB meeting that the research involves no greater than minimal risk and no additional risks have been identified. NO Yes Expedite under category # 1 Send full protocol to IRB for review. No Yes NO To Full Board for Review NOTE: FB does NOT determine SR/NSR status Is study minimal risk? Send study to SOM CTO for IDE opinion and to full board to make SR/NSR Determination. Send protocol to SOM CTO for IDE opinion and to full board for review and SR/NSR Determination Yes Expedite under category # 4 and any other applicable categories. (RUO devices not considered a medical device.) NSR SR Study Involves Device: Overall Summary Use only/No evaluation of device: FDA regulations do NOT apply: expedited via category # 4 Evaluation of Device- FDA regulations DO apply- If device exempt from IDE regulations or NSR and protocol may otherwise be reviewed by expedited review procedures expedite via category # 1. Full Board determines study is SR: Full Board to review protocol . DO NOT expedite review of protocol. Full Board determines study is NSR- Expedite review of protocol under cat# 1.

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